BruxZir Shaded, Model No. 70-1167-NOW0001, 70-1167-NOW0002, 70-1167-NOW0003, 70-1167-NOW0005, 70-1167-NOW0006 The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.
Recall
- Recall Number
- Z-2897-2016
- Event Number
- 75082
- Firm
- Prismatik Dentalcraft, Inc
- FEI Number
- 3011649314
- Product Code
- EIH
- Status
- Terminated
- Root Cause
- Release of Material/Component prior to receiving test results
- Initiated
- August 15, 2016
- Terminated
- December 23, 2016
- Address
- 2181 Dupont Dr, Irvine, CA, 92612-1301
Description
BruxZir Shaded, Model No. 70-1167-NOW0001, 70-1167-NOW0002, 70-1167-NOW0003, 70-1167-NOW0005, 70-1167-NOW0006 The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.
Prismatik Dentalcraft is recalling BruxZir Shaded because the new design was manufactured at risk and were to be quarantined and held until the validation was completed. Prismatik failed to properly identify the lots as quarantined product.
Prismatik DentalCraft, Inc. sent an Urgent Medical Device Recall letter dated August 15, 2016, to all their customers to inform them that Prismatik Dentalcraft is recalling BruxZir NOW product because the new design was manufactured at risk and was supposed to be quarantined and held until validation was completed. Prismatik failed to properly identify the implicated lots as quarantined product. Customers are informed that the BruxZir Now with the thicker sprue design was packaged and shipped to customers in error. Customers are informed of that there is no risk to the patient and of the actions to be taken for the customers and from Prismatic Dentalcraft Inc. For questions regarding this recall call 949-440-2600.
Nationwide distribution to SC, MN, NC, IN, AZ, OR, WA, CA, WY
150 units